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Could a mouthpiece replace sleep lab tests for apnea?

NCT ID NCT07397780

Diagnosis Sponsor: ProSomnus Sleep Technologies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study checks if a special mouthpiece that measures oxygen levels during sleep is as accurate as the standard sleep lab test. Thirty adults with obstructive sleep apnea will wear the device overnight in a sleep lab. If it works well, it might offer a simpler way to track oxygen drops at home.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RPMO2 OSA Device (buccal mucosal oximeter embedded in an oral appliance)
What this could lead to
If accurate, this device could allow people with sleep apnea to monitor their oxygen levels at home without a full sleep lab visit.
What could go wrong
This is a small, early-stage validation study with only 30 participants. The device may not be accurate enough, and results may not apply to everyone with sleep apnea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults with obstructive sleep apnea

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 years or older * Diagnosed with obstructive sleep apnea (per American Academy of Sleep Medicine's definition) * Adequate dentition for oral appliance therapy * Ability to refrain from the use of OSA therapy other than the study device for the week prior to the in-lab sleep study Exclusion Criteria: * Non-respiratory sleep disorders or environmental or personal factors that preclude the accuracy, acquisition, or interpretation of in-lab polysomnography * Pregnancy * In the opinion of the principal investigator, unsuitable for participation in the study

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea

Contacts and locations

Locations

  • Star Sleep and Wellness

    Dallas, Texas, 75251, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.